Adjustable, remote-controllable orthopaedic prosthesis and associated method

ABSTRACT

An implantable, adjustable prosthesis includes a first component which may be moved relative to a second component by use of a transcutaneous control signal. A method of operating such a prosthesis is also disclosed.

This application is a divisional application of U.S. Utility patentapplication Ser. No. 12/491,661 entitled “ADJUSTABLE,REMOTE-CONTROLLABLE ORTHOPAEDIC PROSTHESIS AND ASSOCIATED METHOD” whichwas filed on Jun. 25, 2009 by Mark R. DiSilvestro, and is a continuationof U.S. patent application Ser. No. 11/154,339, filed on Jun. 16, 2005and issued as U.S. Pat. No. 7,559,951 on Jul. 14, 2009, which claimspriority under 35 U.S.C. §119(e) to U.S. Provisional Patent ApplicationNo. 60/615,146, filed on Sep. 30, 2004. Each of those applications isincorporated herein by reference.

FIELD OF THE DISCLOSURE

The present disclosure is related generally to orthopaedic prosthesisand methods of using the same.

BACKGROUND

During the lifetime of a patient, it may be necessary to perform a jointreplacement procedure on the patient as a result of, for example,disease or trauma. The joint replacement procedure may involve the useof a prosthesis which is implanted into one or more of the patient'sbones. In the case of a hip replacement procedure, a femoral prosthesisis implanted into the patient's femur. The femoral prosthesis typicallyincludes an elongated stem component which is implanted into themedullary canal of the patient's femur and a spherically-shaped headwhich bears against the patient's acetabulum or a prosthetic replacementacetabular cup. In the case of a shoulder replacement procedure, ahumeral prosthesis is implanted into the patient's humerus. The humeralprosthesis includes an elongated stem component which is implanted intothe medullary canal of the patient's humerus and a spherically-shapedhead which bears against the patient's glenoid or a prostheticreplacement glenoid component. In the case of a knee replacementprocedure, a tibial prosthesis is implanted into the patient's tibia.The condyle surfaces of the patient's femur, or the condyle surfaces ofa replacement femoral component, bear against the tibial prosthesis.

Subsequent to implantation, there is occasionally the need to adjust theprosthesis. For example, it may be necessary to adjust the prosthesis tocorrect a surgical error or correct for subsidence of the implant. Suchadjustments necessitate one or more revision surgeries.

Moreover, each year in the United States approximately 650-700 childrenunder the age twenty (20) are diagnosed with a malignant bone tumor.When presented with these types of cases, the surgeon can eitheramputate the entire limb or try to preserve it. To preserve the limb,the cancerous portion of the bone is removed. This surgery typicallyinvolves the removal of one or both of the growth plates. Because theresidual bone cannot grow at the same speed as the contralateral bone, amodular endoprosthesis is often implanted. As the child grows, moresurgeries are required to lengthen the device. Depending on the age andcondition of the patient, the number of surgeries that the patient hasto endure can be greater than twenty. Specifically, for the youngpatient to grow properly with a modular endoprosthesis, multiplesurgeries must be completed to continually lengthen the device orreplace it with a new, longer one. After the patient has reached his/herfull height, it may be necessary to replace the endoprosthesis againwith a permanent endoprosthesis.

SUMMARY

According to one aspect of the present disclosure, an adjustableprosthesis includes a first component which may be moved relative to asecond component by use of a transcutaneous control signal.

The prosthesis may include a telescoping stem having an adjustablelength.

The prosthesis may include a telescoping stem having an adjustablelength and a telescoping neck having an adjustable length.

The prosthesis may include a long bone prosthesis having an adjustablelength and an adjustable offset.

The prosthesis may include a tibial component.

According to another aspect of the present disclosure, there is provideda method of operating an implantable prosthesis. The method includesimplanting the prosthesis and thereafter post-operatively adjusting theprosthesis.

The above and other features of the present disclosure will becomeapparent from the following description and the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIGS. 1-3 are diagrammatic views of an adjustable long bone prosthesis;

FIGS. 4-6 are diagrammatic views of an adjustable tibial prosthesis;

FIG. 7 is a cross-sectional view of an adjustable femoral prosthesis;and

FIG. 8 is a cross-sectional view of another adjustable femoralprosthesis.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been shown by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the disclosure to the particular formsdisclosed, but on the contrary, the intention is to cover allmodifications, equivalents, and alternatives following within the spiritand scope of the invention as defined by the appended claims.

As will be described herein in greater detail, the remote-controllableprosthetic implants of the present disclosure allow a surgeon topost-operatively, and in some cases, transcutaneously control certainactions of the implant without the need for revision surgery. Theimplant may be controlled to adjust its physical shape (e.g., length,alignment, offset, thickness, radius), deliver drugs or other compounds,or correct a variety of other conditions. It should be appreciated thatany such control of the implants of the present disclosure may also beperformed intra-operatively if the surgeon so desires. In certainembodiments, the implants of the present disclosure may be configuredwith sensors or other devices which allow the implant to sense orotherwise detect certain conditions and then perform a predeterminedfunction in response thereto.

As shown in FIG. 2, the length of a long bone implant 10, such as afemoral implant, may be adjusted post-operatively to, for example,correct a surgical error or otherwise account for surgical variationsuch as leg length discrepancy subsequent to a hip replacementprocedure. The femoral implant 10 may also be used for thepost-operative correction of instability issues arising from surgicalerror or compromise of the patient's soft tissue (e.g., tissuestretching). In the case of a total hip replacement procedure, stabilitymay be enhanced by moving the neck 12 of the implant 10 proximallyand/or by increasing the offset to tighten the soft tissues (see FIGS.1-3). Similarly, improvement of weak abductor function in a patientfollowing a total hip replacement procedure may be achieved bypost-operatively increasing the offset of the femoral implant 10 (seeFIG. 3).

As shown in FIG. 5, a tibial implant 14 may be adjusted post-operativelyto correct any tibial tray malalignment that may occur following a totalknee replacement procedure. The implant 14 may also be used topost-operatively correct the occurrence of subsidence on either one side(e.g., the medial side, see FIG. 5) or both sides (e.g., both the medialand lateral sides, see FIG. 6) of the knee subsequent to a total kneereplacement procedure. It should be appreciated that althoughmedial/lateral adjustment of the tibial implant 14 is shown in FIGS. 5and 6, such concepts may also be applied to anterior/posterioradjustment of the implant 14. The tibial implant 14 may also be used forthe post-operative correction of instability issues arising fromsurgical error or compromise of the patient's soft tissue (e.g., tissuestretching). In the case of a total knee replacement procedure,stability may be enhanced by raising the proximal surface of the tibialtray (see FIG. 6).

The implants of the present disclosure may also be used to treat anumber of different conditions by releasing a drug or other compoundthat is contained in the implant. For example, an antibiotic may bedelivered to an infected joint from the implant. The implants may beused to release chelating agents or other compounds to capture metalions. The implants may be used to release agents to capture orneutralize wear debris.

Remote control of the implants 10, 14 may be achieved through the use ofa wireless communications link. For example, a radio-frequency (RF) oracoustic link may be used to communicate commands to the implant 10, 14once it has been implanted in the patient. A user interface, such as apersonal computer (PC), laptop, or hand-held computer, may be used toenable communication with the implant, control the action (e.g.,movement) of the implant, and provide feedback to the surgeon as to theaction being performed.

The implant 10, 14 may be configured to include any necessary hardwareand software to perform the desired functions. For example, the implant10, 14 may be configured with a number of actuators, sensors, and othermechanisms to perform and measure an action and provide feedback to theuser (e.g., the surgeon). The implant 10, 14 may also include thenecessary hardware and software to facilitate the wirelesscommunications link, along with any necessary or desired signalprocessing and analysis. The implant 10, 14 may also be embodied with apower source to power the actuators, sensors, and electronics. As willbe discussed in greater detail below, energy to operate the actuators(or other devices) may also be externally provided to the implant (e.g.,transcutaneously). In combination, the implant 10, 14 may be embodiedwith a sensor feedback scheme which facilitates external actuationthereof. For example, the implant 10, 14 may be actuated by atranscutaneous source, with the control of such a source utilizing inputfrom a sensor associated with the implant 10, 14. In such aconfiguration, the sensor may be used to identify the need foractuation. During such actuation, the sensor provides feedback tomonitor the implant's movement.

Numerous types of actuators may be used to facilitate movement of theimplant 10, 14. For example, the implant 10, 14 may be embodied with oneor more stepper motors, drive motors, servomotors, piezoelectricactuators, shape memory alloy actuators, paraffin actuators, linearpiezoelectric motors, electromagnetic solenoids, electroactive polymers,or the like, to drive the movable components of the implant 10, 14. Suchdevices may be driven by a spring bias, fluid pressure, gas pressure,electric current, heat (e.g., nitinol or other shape memory alloychanging shape as a function of temperature change), or other types ofenergy.

Hence, it should be appreciated that an adjustable remote-controllableorthopaedic implant may be designed such that the implant can beactuated via transcutaneous energy transfer and/or an onboard powersource so that the implant's shape, size, offset, alignment, length,etcetera can be adjusted. Multiple actuators may be utilized. A sensor(or multiple sensors) may be used to provide real-time feedback to thesurgeon. Such feedback may be provided to the surgeon via any type ofhuman machine interface. This feedback may be used to facilitateadjustment of the implant to a desired orientation/position.

One specific illustrative embodiment of an implant constructed with theconcepts described herein is a joint space narrowing measurement device.Such a joint space narrowing measurement device may be used to monitorthe distance between two bones (including any implants placed in them).Such a device may also be used to monitor the relative three-dimensionalposition and orientation of one implant component (e.g., the tibialcomponent of a knee prosthesis) with respect to another implantcomponent (e.g., the femoral component of a knee prosthesis). As thejoint space narrows, the device enables a surgeon to identify thenarrowing profile (e.g., medial or lateral dominant or a preciserelative position and orientation of one component with respect toanother indicating levels of subsidence, migration, fixation integrity,and potentially micromotion). An actuator, such as one of the actuatorsdescribed above as well as a magnet driven actuator, may be included ineither joint replacement component (e.g. in the knee, the tibial orfemoral component). As the surgeon identifies the narrowing profileduring a routine post-operative office visit, he or she may also chooseto adjust the alignment/laxity of the components using thetranscutaneously energized actuator. As noted above, the actuator(s) maybe energized by an onboard power source as well. During such adjustment,the joint space narrowing measurement device can be used to providereal-time feedback of the adjustment. This will improve the adjustmentand increase the likelihood that the proper adjustment is made.

Another specific exemplary embodiment of an implant constructed with theconcepts described herein is a responsive orthopaedic implant in whichan on-board sensor (or multiple sensors) and an on-board actuator (ormultiple actuators) are used in combination. In such a case, the sensormonitors some physical, chemical, or other parameter(s). When the sensordetects some absolute or relative change in such a parameter(s), theorthopaedic implant responds by initiating some desirable adjustmentthrough actuation of the on-board actuator. During such actuation, thesensor may continue to monitor the parameter(s). Actuation is terminatedwhen the sensor detects that the parameter(s) has returned to withinpredetermined limits.

Referring now to FIG. 7, there is shown an adjustable femoral prosthesis20 for implantation into a patient's femur during performance of a hipreplacement procedure. It should be appreciated that although theconcepts of the present disclosure are herein exemplarily described inregard to a prosthesis for use in the performance of a hip replacementprocedure, the concepts of the present disclosure may be utilized inregard to a prosthesis for implantation into other bones of the body.For example, the concepts of the present disclosure may be utilized inthe construction of a prosthesis for implantation into the humerus,radius, ulna, tibia, fibula, femur, glenoid, talus, spine, or any of themetatarsals or metacarpals.

The femoral prosthesis 20 includes a stem assembly 22, a body assembly24 movable relative to the stem assembly 22, and a neck 26 movablerelative to the body assembly 24. The neck 26 extends outwardly from thebody assembly 24. A generally spherically shaped prosthesis (not shown)that mimics a natural femoral head may be taper fit or otherwise securedto the neck 26. The prosthesis 20 is configured to be implanted into thefemur of a patient in order to replace certain natural features of thepatient's femur as a result of, for example, disease or trauma. Theprosthesis 20 is implanted into a surgically prepared (e.g., reamedand/or broached) medullary canal of the femur.

The stem assembly 22 and the body assembly 24 of the prosthesis 20 maybe utilized to secure the patient's femur for movement relative to thepatient's pelvis. In particular, the spherically shaped prosthesissecured to the neck 26 is positioned to bear on either the patient'snatural acetabulum or a prosthetic socket in the form of a prostheticcup (not shown) which has been implanted into the patient's pelvis toreplace his or her acetabulum. In such a manner, the prosthesis 20 andthe natural or artificial acetabulum collectively function as a systemwhich replaces the natural “ball and socket” joint of the patient's hip.

Each of the stem assembly 22, the body assembly 24, and the neck 26 maybe made of materials conventionally utilized in the construction ofprosthetic implants. For example, the stem assembly 22, the bodyassembly 24, and the neck 26 may be constructed from implantable metalssuch as stainless steel, cobalt chrome, or titanium, including alloys ofsuch metals. The stem assembly 22, the body assembly 24, and the neck 26may also be constructed with non-metallic materials such asimplant-grade polymers or ceramics.

The stem assembly 22 may be embodied in a number of differentconfigurations in order to fit the needs of a given patient's anatomyand provide a variety of geometries and sizes. In particular, the stemassembly 22 may be configured in various different lengths to conform tothe patient's anatomy (e.g., a relatively long stem assembly 22 for usewith a long femur, a relatively short stem assembly 22 for use with ashort femur, etcetera). Moreover, the stem assembly 22 may also beembodied in a bow-shaped configuration if required by a given patient'sanatomy. Yet further, the stem assembly 22 may also be embodied invarious diameters as required by a given patient's anatomy.

The stem assembly 22 is implanted into an elongated bore surgicallyformed in the patient's femur. As such, the stem assembly 22 may beconstructed with materials which promote bone ingrowth into the outersurfaces of the stem assembly 22. Moreover, since bone cement may beused to secure the stem assembly 22 in the femur, the materials fromwhich the stem assembly 22 is constructed may also be selected topromote interdigitation of bone cement into the outer surfaces of thestem assembly 22.

As shown in FIG. 7, the stem assembly 22 includes an outer shell 28defining an elongated bore 32 therein. Illustratively, the bore 32extends from a proximal end of the stem assembly 22 to a distal end ofthe stem assembly 22 to form a passageway therethrough. As is discussedin greater detail below, a portion of the body assembly 24 is receivedwithin the bore 32 for up and down movement along a longitudinal axis 25which extends the length of the stem assembly 22 relative to the outershell of the stem assembly 22 to adjust an overall length of theprosthesis 20. The body assembly 24, therefore is telescopicallyadjustable relative to the stem assembly 22. The distal end of the bodyassembly 22 is positioned in the elongated bore 32, whereas the proximalend of the body assembly 22 extends out of the bore 32. Illustratively,a proximal end of the bore 32 defines a larger diameter than a distalend of the bore 32. Further, an inner rim 33 of the outer shell 28extends inwardly into the bore 32 to define a lower, distal cavity andan upper, proximal cavity.

The stem assembly 22 further includes an end cap 35 coupled to thedistal end of the outer shell 28. Illustratively, the distal end of thebore 32 includes an inner threaded portion 40 and the end cap 35includes a threaded portion 42 received within the distal end of thebore 32 of the outer shell 28. The end cap 35 further includes an innerbore 44 which communicates with the distal end of the bore 32 of theouter shell 28 to define the lower, distal cavity of the prosthesis 20.The end cap 35 may be made from a polymer such as ultra high molecularweight polyethylene. Illustratively, an o-ring seal 46 is positionedbetween the end cap 35 and the distal end of the outer shell 28 within achannel formed in the end cap 35 to prevent bodily fluids from enteringthe bore 32.

The prosthesis 20 further includes a power source 50, a first driveassembly 52 electrically coupled to and driven by the on-board powersource 50, and a second drive assembly 54 also electrically coupled toand driven by the on-board power source. Illustratively, the first driveassembly 52 is coupled to both the stem assembly 22 and the bodyassembly 24 to move the body assembly 24 relative to the stem assembly22 along the first axis 25 to increase and/or decrease an overall lengthof the prosthesis 20. The second drive assembly 54 is coupled to boththe body assembly 24 and the neck 26 to move the neck 26 relative to thebody assembly 24 to increase and/or decrease an overall offset andlength of the prosthesis 20. Illustratively, the neck 26 is movablelinearly along a second axis 98 extending along a length of the neck 26,as shown in FIG. 7, for example.

As shown in FIG. 7, the power source 50 is positioned within the distalend of the bore 32. A portion of the first drive assembly 52 is alsopositioned within the distal end of the bore 32, with another portion ofthe first drive assembly 52 being positioned within the proximal end ofthe bore 32.

The internal or on-board power source 50 of the prosthesis 20 may beembodied in numerous forms. For example, the power source 50 may be anon-board battery, such as a lithium iodine cell available from WilsonGreatbatch Technologies, Inc. (Clarence, N.Y.). Alternatively, theinternal power source 50 of the prosthesis 20 may be an inductive powersource such as a ferrite-loaded coil. A suitable ferrite-loaded coil isa small wound coil such as that available commercially from Predan SA(Kamanillas, Malaga, Spain). The configuration of such a wound coil maybe based on the design and the selection of the electronic components ofthe prosthesis. For example, the power, frequency, and size of the coilmay be selected to suit the other components of the prosthesis.Alternatively, a suitable ferrite-loaded coil may be wound usingstandard equipment such as that available from Aumann North America,Inc. (Fort Wayne, Ind.). When the coil is passed through an externallygenerated electromagnetic field, an electric current is formed throughthe coil which may be used to power the other components within theprosthesis 20. Other suitable power sources or power generators may beused as well.

For embodiments where the power source 50 includes an inductor, anexternal power source 102 may be provided at the point of care. In anillustrative embodiment, the external power source 102 may form acomponent of an external control system 104, and may include a coil thatgenerates a localized electromagnetic field that acts upon the implantedferrite coil to thereby supply power to the implanted electronics.Suitable external coils are commercially available from Predan SA(Kamanillas, Malaga, Spain). Generally, since the coils are likely to beused in close proximity to the patient, it may be desirable to select ordesign a coil that will not irritate or excessively heat the patient'sskin and that can be easily handled by the operator or medicaltechnician. The coil supplies a field at the desired frequency tostimulate the implanted power coil. Illustratively, the external controlsystem 104 may also include a remote receiver or transceiver 106 toreceive an output signal from any sensor 108 which may be positioned onor within the prosthesis 20. An internal transmitter or transceiver 110associated with the controller 100 of the prosthesis 20 may then operateto transmit the sensor's signal to the external control system 104. Asis discussed below, the external control system 104 may include othercomponents as well.

Referring again to FIG. 7, the first drive assembly 52 includes a motor56, a gear reducer 58 coupled to the motor 56, and a threaded driveshaft 60 coupled to the gear reducer 58. It is also within the scope ofthis disclosure for the first drive assembly 52 to include only themotor 56 and the drive shaft 60. In such an embodiment, the drive shaft60 may then be coupled directly to the motor 56. As mentioned above, thepower source 50 is coupled to and powers the motor 56 of the first driveassembly 52.

Illustratively, the motor 56 may be a DC stepper motor, a DC motor, or arotary piezoelectric motor which has a rotational output. Suitablemotors sized to fit within a prosthesis, such as the prosthesis 20,include, for example, those sold by MicroMo Electronics, Inc(Clearwater, Fla.), Sanyo (Bensenville, Ill.), and/or Aeroflex, MotionControl Products Division (Hauppauge, N.Y.). The gear reducer 58includes an input shaft (not shown) coupled to the output shaft (notshown) of the motor 56, a system of gears (not shown), and an outputshaft (not shown) coupled to the threaded drive shaft 60 to rotate thethreaded shaft 60 in both an advancing direction and a retractingdirection. The gears within the gear reducer 58 operate to reduce therotational speed of the output shaft of the gear reducer 58 as comparedto that of the output shaft of the motor 56.

Illustratively, as shown in FIG. 7, a base 62 of the threaded driveshaft 60 is coupled to the gear reducer 58. The base 62 includes anarrow, neck portion formed to receive a seal, such as an o-ring seal66, therein. Illustratively, the outer shell 28 of the prosthesis 20includes an inwardly extending rib 33 generally aligned with the neck ofthe base 62 of the threaded drive shaft 60.

The threaded end of the threaded drive shaft 60 is received within athreaded bore 67 formed in a distal end of the body assembly 24 of theprosthesis 20. As is described in greater detail below, the motor 56drives the gear reducer 58 to cause the threaded drive shaft 60 torotate. Due to the non-circular shape of the proximal end of the outershell 28 and of the body assembly 24 received within the outer shell 28,the body assembly 24 is prevented from rotating with the threaded driveshaft 60 relative to the outer shell 28. Therefore, the rotationalmotion of the drive shaft 60 is translated to a linear up and downmotion of the body assembly 24 relative to the stem assembly 22. Forexample, when the motor 56 is driven in a first direction, the bodyassembly 24 moves upwardly relative to the stem assembly 22 to increasean overall length of the prosthesis 20. However, driving the motor 56 ina second direction opposite from the first direction causes the bodyassembly 24 to move downwardly relative to the stem assembly 22 todecrease an overall length of the prosthesis 20. As is discussed ingreater detail below, a controller 100 is coupled to the power source 50and the motor 56 to control the power source 50 and the motor 56 inorder to allow the surgeon or technician to adjust the overall length ofthe prosthesis 20 incrementally in a controlled manner.

As mentioned above, the body assembly 24 of the prosthesis 20 ispositioned within the bore 32 of the stem assembly 22 and is located ata generally proximal end of the stem assembly 22. Further as mentionedabove, the body assembly 24 includes the threaded bore 67 formed toreceive the threaded drive shaft 60 of the first drive assembly 52therein. The threaded bore 67 is formed in a distal end of the bodyassembly 24. A second bore 68 is formed in a proximal end of the bodyassembly 24. The second bore 68 extends from a rear surface 70 of thebody assembly 24 to a top, neck surface 72 of the body assembly 24 andis formed to define a first compartment in communication with the rearsurface 70 and a second compartment in communication with the topsurface 72. Illustratively, an annular rib 74 of the body assembly 24extends into the second bore 68 to define the first and secondcompartments.

The second drive assembly 54 is positioned within the second bore 68 andincludes a motor 76, a gear reducer 78 coupled to the motor 76, and athreaded drive shaft 80 coupled to the gear reducer 78. As with thefirst drive assembly 52, the motor 76 of the second drive assembly 54may be a DC stepper motor, a DC motor, or a rotary piezoelectric motor.Illustratively, the motor 76 is coupled to and in electricalcommunication with the power source 50 via an electrical cable 82extending from the power source 50 to the motor 76 of the second driveassembly 54.

Illustratively, a plug 84 of the body assembly 24 is received within thefirst compartment of the bore 68, and an o-ring seal 86 is provided toseal the bore 68 and prevent bodily fluids from entering the bore 68.The plug 84 may be made from a polymer such as UHMWPE, for example. Ano-ring seal 88 is also provided between the gear reducer 78 and thethreaded drive shaft 80.

A base 90 of the threaded drive shaft 80 of the second drive assembly 54is coupled to the gear reducer 78. An output shaft (not shown) of themotor 76 causes both an input and an output shaft (not shown) of thegear reducer 78 to rotate, which in turn causes the threaded drive shaft80 to rotate.

The neck 26 of the prosthesis 20 includes a stem 92 received within thesecond compartment of the bore 68 of the body assembly 24. A tapered end94 of the neck is coupled to the stem 92. The stem 92 includes athreaded bore 96. The threaded drive shaft 80 of the second driveassembly 54 is received within the threaded bore 96. While the motor 76and gear reducer 78 cause the threaded drive shaft 80 to rotate, theneck 26 is prevented from rotating with the threaded drive shaft 80 by akeyed relationship between the neck 26 and the body assembly 24. Forexample, a groove (not shown) may be formed in the stem 92 of the neck26 and a corresponding pin (not shown) may be protruding from an insidesurface of the second compartment of the bore 68 formed in the bodyassembly 24. As such, the pin of the body assembly 24 may be receivedwithin the groove of the neck 26 to operate as an anti-rotation featureto prevent the neck 26 from rotating with the threaded screw drive 80 ofthe body assembly while allowing the neck 26 to linearly translate alongthe axis 98. It is also within the scope of this disclosure for the neck26 to include a pin or key and the body assembly 24 to include acorresponding groove for receiving such a pin or key therein. It isfurther within the scope of this disclosure to provide an anti-rotationfeature between the neck 26 and body assembly 24 by forming the stem 92of the neck 26 and the proximal end of the body assembly 24 in anon-circular or non-round shape (such as, for example, oval,rectangular, or D-shaped) to prevent the neck 26 from rotating with thethreaded drive shaft 80 relative to the body assembly 24.

Rotational movement of the drive shaft 80 and the threaded relationshipbetween the drive shaft 80 and the neck 26 causes the neck 26 to movelinearly along the second axis 98, shown in FIG. 7, relative to the bodyassembly 24. For example, when the motor 76 is driven in a firstdirection, the neck 26 moves outwardly along the second axis 98 in anextending direction away from the body assembly 24 to increase both theoffset and the length of the prosthesis 20. However, driving the motor76 in a second direction opposite the first direction causes the neck 26to translate along the axis 98 in a retracting direction generallytoward the body assembly 24 to decrease both the offset and the lengthof the neck 26 relative to the body assembly 24.

A surgeon or other technician may adjust the length and/or offset of theprosthesis 20 through remote control using a wireless communicationslink. For example, the external control system 104 may include a userinterface, such as a laptop or PC, hand-held personal computer, personaldata assistant, or any custom-designed data acquisition device, forexample, having a wireless link for communication with the controller100 of the prosthesis 20. The controller 100 may be embodied as any typeof electronic controller such as, for example, general purposemicro-controllers, microprocessors, or application specific integratedcircuits (ASICs). Moreover, the controller 100 may further include areceiver, transmitter, or transceiver 110 and a memory device 112 suchas a random access memory (RAM) device. The controller 100 is configuredwith the appropriate hardware, software, and/or firmware to beresponsive to the user commands received via the external control system104.

The controller 100 of the prosthesis 20 is configured to communicatewith the external control system 104 by use of the transceiver 110. Thecommunication link between the controller 100 and the external controlsystem 104 may use any type of suitable communication technology, suchas radio frequency (RF) or an acoustic link. In some embodiments, thecontroller 100 transmits data received from the sensor 108 to theexternal control system 104. In the case of, for example, a positionsensor, the controller transmits data indicative of the relativeposition of one or more of the components of the prosthesis (e.g., thestem assembly, the body assembly, or the neck). The external controlsystem 104 may then display such data to the surgeon via a displaydevice (not shown) such as a monitor or the like associated with thesystem's user interface. Armed with this information, the surgeon maythen adjust the prosthesis 20. For example, the external control system104 may communicate with the controller 100 to, for example, adjust thelength and/or the offset of the prosthesis 20. For instance, theexternal control system 104 may transmit signals to the controller 100which cause the controller 100 to operate the motors 56, 76 of therespective drive assemblies 52, 54 of the prosthesis 20.

As such, the surgeon may communicate with the controller 100 to instructeither motor 56, 76 of the respective drive assemblies 52, 54 to rotatein a first or second direction a particular number of rotations or for aparticular length of time in order to control the adjustment of theprosthesis. For example, the surgeon may send a wireless signal toinstruct either motor 56, 76 to rotate five revolutions in a particulardirection, for example. Alternatively, the surgeon may simply enter aparticular distance or select from a menu a particular distance, such as5 mm, for example, as an amount by which the surgeon would like one ormore of the components of the prosthesis 20 to be adjusted.Illustratively, the end cap 35 of the stem assembly 22 is made from apolymer material to allow RF or other signals to be transmittedtherethrough.

As mentioned above, the prosthesis 20 may include a variety of onboardsensors gathering data and relaying that data back to the user interfaceof the external control system 104. For example, as described above, theprosthesis 20 may include one or more position sensors 108. Thecontroller 100 of the prosthesis 20 may also include a modulator (notshown) to convert the output position signals of the position sensor 108to an encoded signal that can be transmitted from the controller'stransceiver 110 to a location outside the patient's body (e.g., theexternal control system 104). For example, the modulator can encode aparticular position output signal into an RF wave by means of varyingsignal amplitude, frequency, or phase. The output from the modulator istransmitted outside of the patient's body by use of the transceiver'santenna 114. The external control system 104 demodulates and displaysthe data for the surgeon or other technician to read on the userinterface. As such, the surgeon or other technician is provided withreal-time feedback as to the position of the components of theprosthesis 20.

As mentioned above, the plastic end cap 35 of the prosthesis 20 allowssignals to be transmitted from and received by the transceiver 110within the prosthesis 20. Illustratively, the modulator may bepositioned within the bore 32 of the stem assembly 22 and iselectrically coupled to the power source 50. Suitable modulators arecommercially available from Texas Instruments, Inc. (Dallas, Tex.) inthe form of electronic chips. The modulator and transmitter may beprovided as separate elements or may be provided as a single elementcapable of performing both these functions. In other words, thetransmitter/transceiver may include a modulator or a modulatingcomponent. The modulator is also electrically coupled to and powered bythe power source 50.

Looking again to FIG. 7, the transceiver 106 of the external controlsystem 104 may include an antenna 116 (such as an RF antenna in the caseof when RF technology is used) to receive signals from the antenna 114of the prosthesis 20. The external control system 104 may be programmedto demodulate the RF signal transmitted from the antenna 114 of theprosthesis 20. The external control system 104 may be programmed toperform calculations necessary to convert the received and demodulatedsignal to the position sensed by the position sensor. As is discussedabove, the external control system 104 may also be used to sendinstructions to the controller 100 of the prosthesis 20 to allow asurgeon or other technician to remotely operate the prosthesis 20. Assuch, the transceiver 106 of the external control system 104 may beoperated to generate signals (e.g., RF signals) which are received bythe antenna 114 of the prosthesis 20. Such signals may include commandsregarding the control of one or both of the motors 56, 76 of each of therespective drive assemblies 52, 54 of the prosthesis 20, for example. Assuch, the controller 100 of the prosthesis 20 may include a demodulator(not shown) capable of demodulating and reading the signal as a set ofinstructions for operating motor 56 of the first drive assembly 52 andthe motor 76 of the second drive assembly 54. For example, as mentionedabove, a user may type a set of instructions into the user interfacedevice of the external control system 104, thereby operating the motor56 of the first drive assembly 52 to rotate a predetermined number ofrotations (e.g., five rotations). This instruction signal is then sentfrom the external control system 104 to the prosthesis 20 to cause themotor to rotate as instructed to then cause the body assembly 24 totranslate a certain distance, such as 5 mm, for example.

A second prosthesis 120 is shown in FIG. 8. The prosthesis 120 issimilar to the prosthesis 20 shown in FIG. 7 and described above.Therefore, like reference numerals are used for like components.Further, the external control and operation of the prosthesis 120 is thesame as or similar to that described above with respect to theprosthesis 20. The prosthesis 120 includes a first drive assembly 152for telescopically adjusting the body assembly 24 of the prosthesis 120relative to the stem assembly 22 along the first axis 25, and a seconddrive assembly 154 for telescopically adjusting the neck 26 relative tothe body assembly 24 along a second axis 98. Each drive assembly 152,154 is powered by the power source 50.

The first drive assembly 152 includes a linear actuator 156 having alinearly moving output shaft 158 coupled to the body assembly 24 tolinearly translate the body assembly 24 relative to the stem assembly22. The linear actuator 156 is electrically coupled to the power source50. Similarly, the second drive assembly 154 includes a linear actuator176 electrically coupled to the power source 50 and having a linearlymoving output shaft 178 coupled to the neck 26 to linearly translate theneck 26 relative to the body assembly 24. Each of the linear actuators156, 176 may include a piezoelectric actuator such as, for example, onesold by APC International, Ltd. (Mackeyville, Pa.) and/or by PiezosystemJena, Inc. (Hopedale, Mass.), a shape memory alloy actuator such as, forexample, one sold by NanoMuscle, Inc. (Antioch, Calif.), a paraffinactuator such as, for example, one sold by Stansys Research Corporation(Boulder, Colo.), a linear servomotor such as, for example, one sold byAnorad Rockwell Automation (Shirley, N.Y.) and/or Nippon Pulse America,Inc. (Radford, Va.), a linear piezomotor such as, for example, one soldby Nanomotion, Inc. (Ronkonkoma, N.Y.), an electromagnetic solenoid, ora non-commutated DC linear actuator such as, for example, one sold byH2W Technologies, Inc. (Valencia, Calif.). Other suitable linearactuators may be used as well. For example, a suitable linear actuatormay include a linear actuator capable of producing enough force to movethe body assembly relative to the stem assembly and to move the neckrelative to the body assembly. Further, any suitable linear actuatorincludes those linear actuators sized to fit within a standardprosthesis, such as prosthesis 20, and/or any other type of prosthesiswhere movement of two portions relative to one another is desired.Additionally, other linear actuators may include linear actuators whichprovide actuator forces via bending or flexing movements such as, forexample, an electroactive polymer (EAP) actuator.

The prosthesis 120 may also include a first locking mechanism 180, suchas a ratchet, for example, to lock the relative position of the stemassembly 22 and the body assembly 24. The first locking mechanism 180 isshown diagrammatically in FIG. 8 and is coupled to both the stemassembly 22 and the body assembly 24 of the prosthesis 120. A secondlocking mechanism 190 of the prosthesis 120 may also be provided to lockthe relative position of the neck 26 and the body assembly 24. Thesecond locking mechanism 26 is also shown diagrammatically in FIG. 8 andis coupled to both the neck 26 and the body assembly 24 of theprosthesis 120. Suitable locking or ratchet mechanisms may include afriction ratchet or a toothed ratchet. It is also within the scope ofthis disclosure to provide a means for disengaging the first lockingmechanism 180 from the body assembly 24, for example, and/or fordisengaging the second locking mechanism 190 from the neck 26 in orderto allow the body assembly 24 and the neck 26 to be retracted as well asextended. In operation, the ratchet or locking mechanisms 180, 190generally carry some or all of the weight of the patient during a day today loading or activity after the adjustment has been made. Variousratchet or locking mechanisms may include a friction ratchet for linearactuators having a smaller stroke such as piezoelectric drives, forexample, and/or a toothed ratchet for use with linear actuators having alarger stroke such as shape memory alloys and paraffin actuators, forexample. A solenoid may be used to disengage the ratchet or lockingmechanism to allow the mechanism to move in the reverse direction tomaintain the bidirectional movement of the various components of theprosthesis 120.

Implantation of the femoral prosthesis 20 will now be described ingreater detail. Implantation of the femoral prosthesis 120 is the sameas or similar to implantation of the prosthesis 20. As such, descriptionpertaining to the prosthesis 20 only will be provided. Prior toimplantation of the stem assembly 22, the patient's femur is surgicallyprepared. Specifically, the patient's femur is, for example, reamedand/or broached to form the bore in the medullary canal. Thereafter, thebore is filled, or partially filled, with bone cement. The bone cementmay then be allowed to “set-up” for a period of time. Thereafter, thestem assembly 22 is implanted into the femur. Specifically, the distaltip of the stem assembly 22 is first advanced into the opening in theproximal end portion of the prepared femur and thereafter advanced downthe medullary canal. The body assembly 24 of the prosthesis 20 extendsout of the medullary canal of the femur.

In such a way, the femoral prosthesis 20 may be utilized to secure thepatient's femur for movement relative to the patient's pelvis. Inparticular, when implanted in such a manner, the spherically-shapedprosthetic femoral head (not shown) secured to the neck 26 of the bodyassembly 24 is positioned to bear on either the patient's naturalacetabulum or a prosthetic socket in the form of a prosthetic acetabularcup (not shown) which has been implanted into the patient's pelvis toreplace his or her acetabulum. As a result, the femoral prosthesis 20and the natural or artificial acetabulum collectively function as asystem which replaces the natural “ball and socket” joint of thepatient's hip.

Subsequent to implantation of the femoral prosthesis 20, it may becomedesirable to adjust the prosthesis 20. The prosthesis 20 may be adjustedalong a number of different axes. For example, the prosthesis 20 may beadjust along a first axis to change the length of the prosthesis, andadjusted along a second axis to change the offset of the prosthesis.

To increase the length of the prosthesis 20, such as may be needed fromtime to time when the prosthesis 20 is implanted in a growing child, awireless transmission of instructions may be sent to the prosthesis 20from a point of care computer, as discussed above for example, to adjustthe length and/or offset of the prosthesis 20. As mentioned above, theinternal power source 50 powers the motors 56, 76 of the first andsecond drive assemblies 52, 54 which in turn rotate the respectivethreaded drive shaft 60, 80 to cause either axial movement of the bodyassembly 24 along axis 25 or to cause axial movement of the neck 26along axis 98. Such extension of the body assembly 24 increases thelength of the prosthesis 20, while extension of the neck 26 increasesthe both the offset and the length of the prosthesis 20. It should alsobe appreciated that the external control system 104 activates therespective motors 56, 76 to effectuate rotation of the threaded driveshafts 60, 80 transcutaneously thereby eliminating the need tosurgically gain access to the prosthesis 20 to increase the lengthand/or offset thereof.

It should be appreciated that to decrease the length and/or offset ofthe prosthesis 20, such a command may be transmitted via an RF signal tothe prosthesis 20 as well. Specifically, as mentioned above, a commandto change or reverse the rotation of the output shaft of either motor56, 76 causes the respective body assembly 24 and neck 26 to move in aretracting direction along their respective axes 25, 98. Such retractionof the body assembly 24 relative to the stem assembly 22 decreases thelength of the prosthesis 20, while retraction of the neck 26 relative tothe body assembly 24 decreases both the offset and the length of theprosthesis 20. It should also be appreciated that the external controlsystem 104 activates the respective motors 56, 76 to effectuate rotationof the threaded drive shafts 60, 80 transcutaneously thereby eliminatingthe need to surgically gain access to the prosthesis 20 to decrease boththe offset and the length thereof.

As described above, although the concepts of the present disclosure haveherein been exemplarily described in regard to a prosthesis for use inthe performance of a hip replacement procedure, the concepts of thepresent disclosure may be utilized in regard to other prostheses for usein other procedures. For example, the concepts of the present disclosuremay be utilized in the construction of a hip prosthesis for implantationusing minimally invasive techniques. These and other hip prostheses maybe used in either primary or revision procedures. The concepts of thepresent disclosure may also be used in the construction of an adjustabletibial tray for use in a knee procedure. The concepts of the presentdisclosure may also be used in the construction of a spinal implant usedto treat, amongst other things, scoliosis. The concepts of the presentdisclosure may also be used in the construction of fracture managementdevices thereby providing the device with the ability to compress afracture site through external fixators, nails, and/or plates. Theconcepts of the present disclosure may also be used in the constructionof expandable and contractible nails for use in, amongst other things,trauma procedures.

It should be appreciated that one or more miniature displacement sensorsmay be incorporated into the prostheses 20, 120. For example, theprostheses 20, 120 may be embodied with one or more Hall effect sensors,linear variable displacement transducers (LVDT's), differential variablereluctance transducers (DVRT's), reed switches, or the like. Suchsensors may be incorporated into the femoral stem and neck of theadjustable prostheses 20, 120 and used to measure the distance extendedbetween two components. For example, the sensors may be used to monitorthe change in length of the stem and/or the neck in real-time while theprostheses 20, 120 is being adjusted. In a specific example, a Halleffect sensor may be used to monitor the position of the femoral stemand/or neck. During adjustment, the sensor may be used to providereal-time feedback. In addition to the prostheses 20, 120, such sensorsand schemes may also be utilized in the construction of other types ofprostheses.

It should also be appreciated that the output from a position sensor maybe used to adjust the prostheses 20, 120 in response to a change in theposition of the femoral component with respect to the femur in which itis implanted. For example, as the femoral component subsides andtherefore changes its position with respect to the femur, the stem maybe extended to compensate for the subsidence. The sensor, which mayexemplarily be located on the moving shaft, continues to monitor itsposition with respect to the femur. When the sensor has reached aposition with respect to the femur that is within predetermined limits,adjustment of the prostheses 20, 120 ceases. As with before, in additionto the prostheses 20, 120, such sensors and schemes may be utilized inthe construction of other types of prostheses.

While the concepts of the present disclosure have been illustrated anddescribed in detail in the drawings and foregoing description, such anillustration and description is to be considered as exemplary and notrestrictive in character, it being understood that only the illustrativeembodiments have been shown and described and that all changes andmodifications that come within the spirit of the disclosure are desiredto be protected.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the apparatus and methods described herein.It will be noted that alternative embodiments of the apparatus andmethods of the present disclosure may not include all of the featuresdescribed yet still benefit from at least some of the advantages of suchfeatures. Those of ordinary skill in the art may readily devise theirown implementations of an apparatus and method that incorporate one ormore of the features of the present disclosure and fall within thespirit and scope of the present disclosure.

1. An orthopaedic system comprising: an implantable knee prosthesiscomprising: (i) a first component, (ii) a second component, (iii) adrive assembly operable to adjust the position of at least one of thefirst component and the second component relative to the other, (iv) asensor configured to sense the relative position of the first componentand the second component, and (v) an electronic controller electricallycoupled to the sensor so as to receive the output therefrom.
 2. Theorthopaedic system of claim 1, wherein the electronic controller isfurther configured to control operation of the drive assembly.
 3. Theorthopaedic system of claim 1, wherein the electronic controllercomprises an antenna configured to receive signals from outside the bodyof the patient subsequent to the prosthesis being implanted in the bodyof a patient.
 4. The orthopaedic system of claim 1, wherein theimplantable further comprises a power source electrically coupled to thedrive.
 5. The orthopaedic system of claim 1, further comprising anexternal transmitter, wherein the external transmitter is configured totransmit signals from outside the body to the electronic controllersubsequent to the prosthesis being implanted in the body of the patient.6. An orthopaedic system comprising: an implantable knee prosthesiscomprising: (i) an elongated stem assembly, the elongated stem assemblyconfigured to be received in a surgically prepared medullary canal of afemur, (ii) a neck configured to receive a femoral head prosthesis,(iii) a drive assembly operable to adjust the position of at least oneof the elongated stem component and the neck relative to the other, (iv)a sensor configured to sense the relative position of the elongated stemand the neck, and (v) an electronic controller electrically coupled tothe sensor so as to receive the output therefrom.
 7. The orthopaedicsystem of claim 6, wherein the electronic controller is furtherconfigured to control operation of the drive assembly.
 8. Theorthopaedic system of claim 6, wherein the electronic controllercomprises an antenna configured to receive signals from outside the bodyof the patient subsequent to the prosthesis being implanted in the bodyof a patient.
 9. The orthopaedic system of claim 6, wherein theimplantable further comprises a power source electrically coupled to thedrive.
 10. The orthopaedic system of claim 6, further comprising anexternal transmitter, wherein the external transmitter is configured totransmit signals from outside the body to the electronic controllersubsequent to the prosthesis being implanted in the body of the patient.11. An orthopaedic implant, comprising: an implantable knee prosthesis,comprising: an elongated stem assembly, a neck component, a first driveassembly coupled to the elongated stem assembly and configured to movethe elongated stem assembly along a first axis, a second drive assemblycoupled to the neck component and configured to move the neck componentalong a second axis, the second axis being different than the firstaxis, and a power source secured to at least one of the elongated stemassembly and the neck component, wherein the power source iselectrically coupled to both the first drive assembly and the seconddrive assembly.
 12. The adjustable prosthesis of claim 11, furthercomprising a controller secured to at least one of the elongated stemassembly and the neck component, wherein the controller is configured tocontrol operation of both the first drive assembly and the second driveassembly.
 13. The orthopaedic system of claim 12, further comprising anexternal transmitter, wherein the external transmitter is configured totransmit signals from outside the body to the electronic controllersubsequent to the prosthesis being implanted in the body of the patient.14. The orthopaedic system of claim 13, further comprising an externalreceiver, wherein the external receiver is configured to receive signalsgenerated by the electronic controller from within the body subsequentto the prosthesis being implanted in the body of the patient.
 15. Theadjustable prosthesis of claim 11, further comprising a position sensorconfigured to sense the position of at least one of the elongated stemassembly and the neck component.